The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses

NCT03525847 | Completed DMC

• 1 other identifier: 10430
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy

Conditions

Endoscopic Ultrasonography

Keywords

Contrast endosonograpy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods

  Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods

  an average of 2 years

Secondary Outcomes (3)

• Quality of histological specimen(histology core) obtained with the two types of FNA biopsies (contrast enhanced and standard)

  5 days

• Dysfunction in the two types of biopsies

  day one

• Comparison between standand endosonography and contrast enhanced endosonography in obtaining a superior quality in obtaining histology core

  day one

Study Arms (2)

contrast enhanced FNA endosonography

ACTIVE COMPARATOR

First passage in the solid pancreatic tumor using FNA endosonography then with the contrast enhanced FNA endosonography

Diagnostic Test: Endosonography

FNA standard endosonography

ACTIVE COMPARATOR

First passage in the solid pancreatic tumor using contrast enhanced FNA endosonography then with the FNA endosonography

Diagnostic Test: Endosonography

Interventions

Endosonography DIAGNOSTIC_TEST

Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization

FNA standard endosonography; contrast enhanced FNA endosonography

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• solid pancreatic tumor lesions

You may not qualify if:

• severe coagulopathy of trombocytopenia \<50.000
• patients refuse for biopsy prelevation or pacient's refuse to participate in the study

Sponsors & Collaborators

• Professor Dr. Seicean Andrada: lead

Study Sites (1)

Seicean Andrada

Cluj-Napoca, Cluj, Romania

Location

Related Publications (3)

• Hou X, Jin Z, Xu C, Zhang M, Zhu J, Jiang F, Li Z. Contrast-enhanced harmonic endoscopic ultrasound-guided fine-needle aspiration in the diagnosis of solid pancreatic lesions: a retrospective study. PLoS One. 2015 Mar 20;10(3):e0121236. doi: 10.1371/journal.pone.0121236. eCollection 2015.

  PMID: 25793739 BACKGROUND

• Yoshinaga S, Suzuki H, Oda I, Saito Y. Role of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for diagnosis of solid pancreatic masses. Dig Endosc. 2011 May;23 Suppl 1:29-33. doi: 10.1111/j.1443-1661.2011.01112.x.

  PMID: 21535197 BACKGROUND

• Seicean A, Jinga M. Harmonic contrast-enhanced endoscopic ultrasound fine-needle aspiration: Fact or fiction? Endosc Ultrasound. 2017 Jan-Feb;6(1):31-36. doi: 10.4103/2303-9027.196917.

  PMID: 28218198 RESULT

MeSH Terms

Interventions

Endosonography

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Seicean Andrada

  Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"Cluj-Napoca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator Proffesor Dr Phd Md

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: May 16, 2018
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)